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Biosyn Selects TraceLink to Align Regulations

TraceLink will help biosyn to ensure compliance with the EU Falsified Medicines Directive (FMD) requirements

By: Betsy Louda

, Contract Pharma

TraceLink announced that biosyn Arzneimittel GmbH has selected TraceLink’s serialization solutions to ensure compliance with the EU Falsified Medicines Directive (FMD) requirements.

 

With a large customer base in Europe, biosyn needed a serialization solution that would ensure on-time compliance with the EU FMD regulations through a simple and direct path to the European hub. As biosyn works with multiple contract manufacturers, the chosen solution would need to simplify connectivity and enable the seamless exchange of data. The solution also needed to meet requirements in South Korea, Brazil and other future markets.

 

“We have customers and partners located all over the world and could not afford to lose time and resources by establishing individual point-to-point connections. After a thorough evaluation of solution providers, it was clear that TraceLink’s network approach would deliver the scalability we needed while providing a simple and fast connection into the EU hub,” said Ortwin Kottwitz, chief executive officer of biosyn.

 

“EU FMD compliance is becoming a stark reality for companies that need to have new technologies and processes fully implemented and connected into the EU hub by the February 2019 deadline. biosyn values our expertise on EU FMD and country compliance and chose TraceLink for its enterprise scalability and ability to simplify serialization challenges,” said Shabbir Dahod, chief executive officer of TraceLink. 

 

TraceLink has already processed compliance reports for more than 150 million units of product in the EU, China, Brazil, India and South Korea.

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